The FDA announced yesterday that it had for the first time approved a daily birth-control pill for over-the-counter sales. That’s a big change; once the product, called Opill, is on the market—which may be as soon as early 2024—Americans will be able to buy daily hormonal birth control without a prescription. That’s historic news, but hidden underneath it is another set of firsts: In the coming months, Americans will also be able to grab an over-the-counter treatment for their heavy periods, cramps, headaches, and even migraines; they’ll have prescription-free access to a drug for endometriosis and polycystic ovary syndrome; and they’ll be able to buy a medication that can mitigate the symptoms of menopause. It’s all in the same, progestin-based pill.
The FDA’s approval only covers Opill’s use as a form of birth control, but doctors have been prescribing pills that contain progestin for noncontraceptive needs for years. For the most part, the intervention works much better when the pills include both progestin and estrogen. Adding that second hormone to the mix amplifies all of progestin’s beneficial effects, plus helps control hormonal acne. It also leaves more wiggle room in terms of timing: Progestin-only pills—sometimes called a minipill—have a much shorter half-life in the body, so if you don’t take them during the same three-hour window each day, they’re much less reliable at preventing pregnancy, says Anne-Marie Amies Oelschlager, the chief of pediatric and adolescent gynecology at Seattle Children’s. (Some women are prescribed progestin-only pills because they are particularly susceptible to certain risks associated with estrogen.)
As a result, an over-the-counter progestin-only pill is far from the best way of treating these conditions, experts told me. “While I suppose that it could be used off-label, I would be hesitant to do that if someone was otherwise able to obtain a prescription for a combined oral contraceptive,” Erin Fleurant, a family-planning fellow at Northwestern Medicine, told me. And if progestin by itself really were the right approach, then an IUD, implant, or injection might be a more effective way to deliver the drug.
Despite the fact that progestin on its own would not usually be a doctor’s first choice—“I generally don’t prescribe it,” Veronica Ades, the vice chair of ob/gyn at Jacobi Medical Center, told me—the drug can have meaningful benefits when taken on its own. Amies Oelschlager told me that she prescribes it to suppress patients’ periods, especially if they’re experiencing pain or heavy bleeding. Even low-dose pills (like Opill) can be helpful for controlling period- and perimenopause-related migraines, as well as mood swings from premenstrual syndrome or premenstrual dysphoric disorder.
Progestin pills can also be used to treat endometrial hyperplasia, an abnormal thickening of the uterine lining (a.k.a. the endometrium) that can develop into cancer. Same for endometriosis, a condition that may affect up to 11 percent of American women in which endometrial tissue grows outside the uterus. Patients with PCOS produce unusually high levels of male sex hormones and, Ades said, generally have too much estrogen in their body relative to progesterone (the naturally occurring analogue of progestin). Progestin pills can help strike a healthier balance.
Right now, patients have few options to get relief from any of those symptoms without a doctor’s help. Until Opill hits the market, the best non-prescription way to treat PCOS is with healthy eating and exercise, Amies Oelschlager told me. For heavy periods, the best option patients can buy without a prescription is an NSAID like ibuprofen. “As far as an over-the-counter, daily hormonal medication, this is the first in the United States,” she said.
Perhaps the best circumstances for off-label use of Opill will be as a stopgap. If someone starts having abnormal bleeding or period pain but can’t get an appointment or travel to a doctor for several weeks, they could buy themselves some progestin-only pills for the interim. Opill could also be a backup plan for patients who are already taking birth-control pills for a non-birth-control purpose but can’t make it to their doctor to renew their prescription, or can’t get their prescription filled at a pharmacy.
Still, Ades cautioned that even stopgap use might not be wise for endometriosis patients, for whom switching medications could disrupt a delicate balance of hormones and “create a cascade of problems.” Fleurant warned that some of the symptoms that progestin pills could help alleviate may also be associated with very serious conditions that need a different treatment plan. “Say someone was 45 years old and having irregular bleeding and also had a lot of other risk factors for uterine cancer. I wouldn’t want them to pick up this pill and think that that was going to cure everything,” she said. Instead, they should be seen by a health-care provider.
For most women who need to be on birth control, a single-hormone drug like Opill is not the most reliable option; but starting next year, it could well be the most convenient. That same trade-off, between effectiveness and access, affects other uses of progestin, too.
Rachel Gutman-Wei
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